Study Supports Dabigatran Anticoagulant Reversal Agent

New study results suggest idarucizumab is an effective reversal agent for Boehringer Ingelheim's novel oral anticoagulant (NOAC), dabigatran (Pradaxa).

The proof-of-concept investigation, which was published in The Lancet, described how idarucizumab led to immediate, complete, and sustained reversal of Pradaxa-induced anticoagulation in healthy volunteers, supporting its use in emergency situations where such reversal was needed.

Study participants received idarucizumab 2 hours after their last dose of dabigatran, when dabigatran concentrations were at peak levels. Complete anticoagulation reversal was achieved with a single 5-minute infusion of idarucizumab, and this effect was sustained for more than 24 hours. Furthermore, idarucizumab was well tolerated by the participants.

In a statement, Jörg Kreuzer, vice president of Boehringer Ingelheim's cardiovascular medicine therapeutic area, said these results “show in an impressive manner how effective idarucizumab was for reversing Pradaxa in healthy volunteers.”

“Once approved, the availability of a specific reversal agent for a NOAC will be yet another landmark in anticoagulation care,” Kreuzer said.

The FDA granted Breakthrough Therapy designation to idarucizumab in June 2014, and the agency is currently reviewing the drug’s Biologics License Application.

These study results are now part of the FDA’s ongoing regulatory review for idarucizumab’s approval. Further related trials are still in progress.